Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men

Summary

Men sustain over one-third of osteoporosis-related fractures worldwide. The burden of osteoporotic fractures in older men is substantial, and men suffer significantly worse fracture-related outcomes than women. Following a fracture, men sustain greater rates of subsequent fractures, loss of autonomy, and mortality than women and the imminent risk of re-fracture is several times higher in men than in women. Functional mobility, known to predict falls and fractures, is also notably worse in men following a fracture. In the fiscal year 2007-08, the overall annual costs of osteoporosis in Canadian men was evaluated to be $910 million.

Osteoporosis is primarily considered a disease of older women, and men are remarkably under-evaluated and under-treated for it. Recognition of sex and gender influences on skeletal health in men has been very slow; akin to the gap in cardiovascular diseases, where women are far less likely to receive guideline-recommended investigations and treatment.

Over 85% of Canadian men who suffer from fragility fractures do not receive osteoporosis screening and/or treatment strategies. The existence of this care gap in men underscores our current struggle to overcome important barriers including: 1) men's lack of awareness of the critical impact of osteoporosis and fractures on several aspects of their lives, and of the benefits of treatment; and 2) the absence of comprehensive and accessible treatments tailored to men.

Informed by the Knowledge-to-Action framework, we aim to address these barriers by adapting interventions with proven efficacy to engage men at high fracture risk in health behaviour change.

The current protocol is for a pilot RCT to determine the feasibility of recruitment and retention, adherence to, and acceptability of the virtually-delivered fracture prevention intervention only.

Our long-term goal is to conduct a large pragmatic randomized controlled trial (RCT) to address the research question: In older adults at high risk for fractures who self-identify as men, does anti-osteoporosis pharmacotherapy in conjunction with a virtually-delivered intervention that includes a gender-tailored strength training and balance based exercise program and nutritional counselling, improve functional mobility compared to anti-osteoporosis pharmacotherapy in conjunction with an attention control intervention.

Conditions

• Osteoporosis
• Osteoporotic Fractures
• Osteoporosis, Age-Related
• Muscle Loss
• Men
• Aging

Interventions

BEHAVIORAL

Multifaceted Virtual Fracture Prevention Program

* Personalized exercise prescription: Comprised of muscle strengthening and balance exercises to perform three times a week, delivered and monitored remotely via the MisterFit app, a branded version of the secure commercially available Wibbi app (wibbi.com) and monthly virtual exercise consultations. * Virtual nutrition counseling from a registered dietitian in months 2, 4 and 6: to encourage participants to meet daily targets for calcium and vitamin D (preferably from diet), and protein intake to support muscle accretion and target weight maintenance * Virtual interactive information sessions in month 4 and 8: to education participants on topics identified as important by the Misterfit patient partner advisory committee.

BEHAVIORAL

Attention Control

* Encouraged to meet the 24-Hour Movement Guidelines for adults aged 65 years or older (https://csepguidelines.ca) with telephone contacts at the same frequency that the Misterfit online group receives virtual exercise consultations * Nutritional fact sheets: sent by e-mail at the same frequency that the Misterfit online group meets with the research dietitian. * Educational fact sheets: sent by e-mail at the same frequency that the Misterfit Online group has virtual interactive information sessions

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Principal Investigators

• Suzanne Morin, MD · Research Institute of the McGill University Health Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-07

Primary Completion

2026-03-31

Completion

2026-03-31

Countries

• Canada

Study Locations